Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only, Manfactured for Hospira, Inc., Lake Forest, IL 60045 USA.

FDA recall notice · announced December 11, 2013 · Hospira

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only, Manfactured for Hospira, Inc., Lake Forest, IL 60045 USA.

Reason for recall

Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck.

Notes

Distribution: Nationwide
Lot/code information: Lot #17368EV Exp 08/13
Quantity: 29,700 vials
Status: Terminated
Products in this recall event:
- Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only, Manfactured for Hospira, Inc., Lake Forest, IL 60045 USA. (D-023-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.